Q2 2022 Inovio Pharmaceuticals Inc Earnings Call

turn the call over to Novia's president and CEO , Dr. Jackie Shea. Thank you, Thomas. Good afternoon and thank you, everyone, for joining today's call. At Novia, our goal is to bring DNA medicine to market to help address unmet medical conditions and improve the health of people around the globe.

Thomas Hong: over to Novio's president and CEO, Dr. Jackie Scheneges. Thank you, Thomas.

Jacqueline E. Shea: Good afternoon, and thank you everyone for joining today's call. At Anovio, our goal is to bring DNA medicines to market to help address unmet medical conditions and improve the lives of people around the globe. We are dedicated to achieving this goal by building a leading biotechnology company with an innovative pipeline of DNA medicine candidates, from early research through late stage clinical development to commercialization. During the second quarter, we focused on reshaping our organizational structure to align with our product development goals. We announced cost-cutting measures, including a corporate reorganization that resulted in an 18% reduction in our full-time workforce and an 86% reduction in contract work.

We are dedicated to achieving this goal by building a leading biotechnology company with an innovative pipeline of DNA medicine candidates, from early research through late stage clinical development to commercialization. During the second quarter, we focused on reshaping our organizational structure to align with our product development goals.

We announced cost-cutting measures, including a corporate reorganization that resulted in an 18% reduction in our full-time workforce and an 86% reduction in contractors.

Jacqueline E. Shea: These initiatives are expected to reduce our operating expenses by approximately 30% over the next 18 months and extend our cash runway into the third quarter of 2025. In addition, we also strengthened our executive leadership team and our NB organization with the addition of Dr. Michael Sumner and Novio's new chief medical officer. I would have been a strong addition to Anovio, bringing proven experience, strategy, and leadership to bear as we develop cutting-edge product candidates across multiple therapeutic areas. I'm pleased that Mike is already delivering great value through his insights and experiences, having taken several clinical products through to commercialization. I'd like to turn the call over to Mike now to briefly introduce himself. Mike?

These initiatives are expected to reduce our operating expenses by approximately 30% over the next 18 months and extend our cash runway into the third quarter of 2024.

In addition, we also strengthened our executive leadership team and our ND organization with the addition of Dr. Michael Sumner, Anovio's new Chief Medical Officer.

Mike has been a strong addition to Inovio, bringing proven experience, strategy, and leadership to bear as we develop cutting edge product candidates across multiple therapeutic categories.

I'm pleased that Mike is already delivering great value through his insights and experiences, and I've been taking several clinical products through to commercialization.

I'd like to turn the call over to Mike now to briefly introduce himself. Mike? Thank you very much, Jesse. And greetings everyone.

Michael Sumner: Thank you very much, Jesse. And greetings, everyone. I joined Enovio due to the immense potential of our DNA medicines platform and my desire to be part of the team that delivers on that promise. Anobio's DNA medicines are capable of generating immune responses that have the potential for meaningful clinical impact across multiple therapeutic areas. The data the organization has generated to date provides a solid foundation and compelling argument that reinforces our excitement about our existing pipeline as well as the potential of our platform.

I joined Inovio due to the immense potential of our DNA medicines platform and my desire to be part of the team that delivers on that promise.

Anovio's DNA medicines are capable of generating immune responses that have the potential for meaningful clinical impact across multiple therapeutic areas.

The data the organization has generated to date provides a solid foundation and compelling argument that reinforces our excitement about our existing pipeline as well as the potential of our platform.

Michael Sumner: I look forward to working with Jackie and the team to continue sharpening our focus across our pipeline and advancing those product candidates that have the highest commercial potential. I would like to provide an update on our clinical programs for HPV-related disease. On our prior earnings call, we announced our intention to amend the trial design for Reveal 2. Our phase three trial evaluating VTX 3, 3100, at treatment for HPV associated cervical, high-grade squamous intra-epithelial lesions or H. I want to share that the amendments to revise the primary analysis population from the all-comers population to the biomarker positive population have been submitted and that the last patient visit is slated for September.

I look forward to working with Jackie and team to continue sharpening our focus across our pipeline and advancing those product candidates that have the highest commercial potential.

I would like to provide an update on our clinical programs for HPV associated diseases.

On our prior earnings call, we announced our intention to amend the trial design for Reveal-2, our phase 3 trial evaluating VTX 3100, our treatment for HPV associated cervical high-grade squamous intraepithelial lesions or H cell.

I want to share that the amendments to revise the primary analysis population from the all comers population to the biomarker positive population have been submitted and that the last patient visit is slated for September . Therefore we are still on track to report efficacy and safety follow-up data through week 40 by later this year or early next year. I'd also like to remind you that the

Michael Sumner: Therefore, we are still on track to report efficacy and safety follow-up data through week 40 by later this year or early next year. I'd also like to remind you of what we said last quarter regarding the FDA's recommendation about what they see as the most likely part supporting an approval of a marketing application. As you might recall, the FDA recommended that we use Reveal 2 as an exploratory study to evaluate a biomarker-selected population and then conduct one or two additional well-controlled trials in the biomarker positive population. As we said last time, we will assess the path forward for the VGX-30-100 program following the analysis of the Reveal 2 results.

what we said last quarter regarding the FDA's recommendation about what they see as the most likely path supporting an approval of a marketing application. As you might recall the FDA recommended that we use Reveal 2 as an exploratory study to evaluate a biomarker selected population and then conduct one or two additional well-controlled trials in the biomarker positive population.

As we said last time, we will assess the path forward for the VGX3100 program following the analysis of the Revealed 2 results.

Michael Sumner: Even with this disappointing adjustment for our VGX 3100 program, we continue to believe in the potential of our DNA medicine technology to positively impact HPV-related diseases. During the second quarter, we continued to advance our phase one-two study with IMO 307 in patients with recurrent respiratory papillomatosis or RRP. We still expect to be able to share preliminary efficacy, safety, and immunogenicity data from a portion of that trial of participants in the second half of this year. Data from prior clinical studies suggest that IMO-3107 may provide a clinical benefit and an alternative to surgery for patients that suffer from this often lifelong debilitating disease.

Even with this disappointing adjustment for our VGX3100 program, we continue to believe in the potential of our DNA medicines technology to positively impact HPV-associated diseases.

During the second quarter, we continue to advance our phase 1-2 study with INO 3107 patients with recurrent respiratory papillomatosis or RRP.

We still expect to be able to share preliminary efficacy, safety, and immunogenicity data from a portion of that trial's participants in the second half of this year.

Data from prior clinical studies suggest that IMO 3107 may provide a clinical benefit and an alternative to surgery for patients that suffer from this often lifelong debilitating disease.

David Leeuowitz: I will now turn over the call to Dr. David Leeuowitz, our SPP for clinical development of infectious diseases, and our COVID-19 clinical lead, to provide an update on our COVID-19 program. Thank you very much, Mike. And greetings, everyone.

I will now turn over the call to Dr. David Leibowitz, our SVP of Clinical Development of Infectious Diseases and our COVID-19 clinical lead to provide an update on our COVID-19 program. David.

David Leeuowitz: As shared in our last quarterly update, one of our key strategic programs we've been working on over the last several months is our heterologous booster strategy for INO 4800. Public health officials around the world continue to state that additional COVID-19 vaccines that are well-tolerated, temperature stable, and elicit strong and broad immune responses are still needed. The immunogenicity and safety profile that INO 4,800 has shown to date demonstrates its potential as a meaningful tool in the fight against current and future strains of SARS-COVIDs.

Thank you very much, Mike, and greetings everyone. As shared on our last quarterly update, one of our key strategic programs we have been working on over the last several months is our heterologous booster strategy for INO 4800.

Public health officials around the world continue to state that additional COVID-19 vaccines that are well tolerated, temperature stable, and elicit strong and broad immune responses are still needed.

The immunogenicity and safety profile that INO 4800 has shown to date demonstrates its potential as a meaningful tool in the fight against current and future strains of SARS-CoV-2.

David Leeuowitz: There are several factors that support our COVID-19 strategies. One, the continuing emergence of new variants of concern and the subsequent waves of infection, to the shrinking market for primary series vaccines. And three, increasing evidence that points to the superiority of heterologous boosts over homologous ones in generating a protective immune response.

There are several factors that support our COVID-19 strategy.

One, the continuing emergence of new variants of concern and the subsequent waves of infection.

Two, the shrinking market for primary series vaccination.

And three, increasing evidence that points to the superiority of heterologous boosters over homologous ones in generating protective immune responses.

David Leeuowitz: As part of these efforts, we await the final data analysis from the heterologous boost trial with INO-4800 being conducted by our partner, ADVaxine, in China. This non-inferiority trial evaluates INO-4800 as a booster by measuring immune responses in participants who have received an inactivated COVID-19 vaccine and comparing them with the immune responses generated by a homologous boost with that inactivated. We had originally expected this data by the end of summer, but recent lockdowns in China from the resurgence of COVID-19 have affected laboratories and slowed the analysis of the data. We now expect to be able to share the unblinded humoral response data from the trial in the late third quarter of 2020. Turning now to our DMAP technology.

As part of these efforts, we await the final data analysis from the heterologous BOOST trial with INO4800 being conducted by our partner, AddVaccine, in China.

This noninferiority trial evaluates INO4800 as a booster by measuring immune responses in participants who have received an inactivated COVID-19 vaccine and comparing them with the immune responses generated by a homologous boost with that inactivated vaccine.

We had originally expected this data by end of summer, but recent lockdowns in China from the resurgence of COVID-19 have affected laboratories and slowed the analysis of the data.

We now expect to be able to share the unblinded humoral response data from the trial in the late third quarter of 2022.

Jeffrey Skolnick: In the second quarter, our partner, the Wistar Institute, announced a phase one study involving DMAB technology. This Wistar-led study is a collaboration of AstraZeneca, University of Pennsylvania, Indiana University, and Inovio to develop anti-Sars COVID-2 specific DMA, funded by a $37.6 million grant from DARPA JPO, The Phase 1 Open Label Single Center 24-patient dose escalation study is evaluating the safety, tolerability, and pharmacokinetic profile of antithars COVID-2-specific demabs based on AstraZeneca's COVID-19-specific monoclonal antibodies.

Turning now to our DMAP technology.

In the second quarter our partner the with star Institute announced a phase one study involving DMAB technology This with star led study is a collaboration of AstraZeneca University of Pennsylvania Indiana University and Inovio to develop anti SARS kobe 2 specific DMAB

Funded by a 37.6 million dollar grant from DARPA JPO.

The phase one open label single center 24 patient dose escalation study is evaluating the safety, tolerability and pharmacokinetic profile of anti SARS, Kobe to specific D maps based on AstraZeneca's COVID-19 specific monoclonal antibodies.

Jeffrey Skolnick: With regard to our other infectious disease vaccine candidates, we are still on track to announce data for our Phase 2A trial for Middle East Respiratory Syndrome and our Ebola booster study in the second half of this year. The data for our phase one trial of INO-4500 for loss of fever, which we had previously guided to read out in the first half of 2022, is currently being analyzed by Inovio and our partner Cepa. We expect to complete our analysis and share data on INO 4,500 later this year. I'll now turn the call over to Novia's SVP of clinical development, Dr. Jeffrey Skolnick, for an update on our GBM program. Jeffrey?

With regards to our other infectious disease vaccine candidates, we are still on track to announce data for our phase 2, a trial. for Middle East Respiratory Syndrome and our Ebola booster study in the second half of this year.

The data for our phase one trial of INO4500 for Lassa fever, which we had previously guided to read out in the first half of 2022, is currently being analyzed by Inovio and our partner CEPI. Thank you for listening to a full video Gundam

We expect to complete our analysis and share data on INO4500 later this year.

I'll now turn the call over to Novio's SVP of Clinical Development, Dr. Jeffrey Skolnick, for an update on our GBM program.

to Novio's SVP of clinical development, Dr. Jeffrey Skolnick, for an update on our GBM program. Jeffrey?

Jeffrey Skolnick: Thank you, Dave. During the quarter, Enovina announced additional results from our novel Phase 1-2 trial of INO 5401 and INO-9012 in combination with regenerons PD1 inhibitor TIO in 52 patients with newly diagnosed glioblastoma or GBM. The median overall survival for unmethalated MGMT patients or cohort A was 17.9 months, while median overall survival in MGMT methylated patients or cohort B was 32.5 months.

Thank you, Dave.

During the quarter, Inovio announced additional results from our novel phase 1 and 2 trial of INO5401 and INO9012 in combination with Regeneron's PD-1 inhibitor with TIO, and 52 patients with newly diagnosed glioblastoma or GBM.

Median overall survival for unmethylated MGMT patients or cohort A was 17.9 months, while median overall survival in MGMT methylated patients or cohort B was 32.5 months.

Jeffrey Skolnick: Survival data for cohort B compared favorably to historical controls, about 23.2 to 25 months. The results from cohort B were presented for the first time at the 2022 American Society of Clinical Oncology Annual Meeting held this past June. Overall, INO 5401 and INO-9012 were seen in the trial to be tolerable and immunogenic when administered with Liptio and radiation in tamazolamide to newly diagnosed GBM patients.

The survival data for cohort B compares favorably to historical controls.

about 23.2 to 25 months.

The results from Cohort B were presented for the first time at the 2022 American Society of Clinical Oncology Annual Meeting held this past June .

Overall, INO5401 and INO9012 were seen in the trial to be tolerable and immunogenic when administered with libtio and radiation in temozolomide to newly diagnosed GBM patients. And as we concluded in the abstract, INO5401 and INO9012 elicit robust immune responses.

Peter D. Kies: And as we concluded in the abstract, INO-501 and INO-9012 elicit robust immune responses that may correlate with potentially enhanced survival when administered with Lytokaya and the radiation team of OMI, two newly diagnosed GBM patients. Kinovi remains encouraged with progress to date from this novel combination therapy study, and our goal is to build upon INO-50401's ability to elicit antigen-specific T-cells that can infiltrate And now I'll turn the call over to our CFO, Peter Tees, for our second quarter financial summary. Peter?

that may correlate with a potentially enhanced survival when administered with LeTayo and radiation T-Mozolomide, two newly diagnosed GBM patients.

Inobi remains encouraged with progress to date from this novel combination therapy study. And our goal is to build upon INO5401's ability to elicit antigen-specific T cells that can infiltrate tumors and improve patient survival within a combination regimen.

And now I'll turn the call over to our CFO , Peter Teves, for our second quarter financial summary. Peter? I'm Peter Teves, and I'll turn the call over to our CFO , Peter Teves, for our second quarter

Peter D. Kies: Thanks, Jeffrey, and good afternoon, everyone. We finished the second quarter with 348.1 million in cash, cash equivalents, and short-term investments, compared to 360.4 million as of March 31st, 2022. As of June 30, 2022, Anobio had 247.5 million shares of common stock outstanding, and 267,000, 0.8 million shares of common stock outstanding on a fully diluted basis.

Thanks Jeffrey, and good afternoon everyone. We finished the second quarter with $348.1 million in cash, cash equivalents, and short term investments.

compared to $360.4 million as of March 31, 2022. As of June 30, 2022, Inovio had 247.5 million shares of common stock outstanding and 267.8 million shares of common stock outstanding on a fully diluted basis.

Peter D. Kies: Our total revenue was $784,000 for the three months ended June 30th, 2022, compared to $273,000 for the same period in 2021. The increase in revenue... resulted from the delivery of Anovio's proprietary smart devices related to our contract with the U.S. Department of Defense. Total operating expenses were 104.9 million for the three months ended June 30th, 2022, compared to 83.5 million for the same period in 2021. Our net loss for the three months ended June 30th, 2022, was 108.5 million, or 46 cents per share, basic and dilutive, compared to a net loss of 82.1 million, or 39 cents per share, basic and dilutive, for the quarter ended June 30th, 20 Anobio's research and development expenses for the three months ended June 30, 2022, were 56.5 million, compared to 70.8 million for the same period in 2021.

Our total revenue was $784,000 for the three months ended June 30, 2022, compared to $273,000 for the same period in 2021. The increase in revenue...

resulted from the delivery of Inovio's proprietary smart devices related to our contract with the U.S. Department of Defense.

Total operating expenses were $104.9 million for the three months ended June 30, 2022, compared to $83.5 million for the same period in 2021.

Our net loss for the three months ended June 30th, 2022 was $108.5 million, or $0.46 per share, basic and dilutive.

compared to a net loss of 82.1 million.

or $0.39 per share, basic and dilutive, for the quarter ended June 30, 2021.

Inovio's research and development expenses for the three months ended June 30, 2022, were $56.5 million compared to $70.8 million for the same period in 2021.

Peter D. Kies: The decrease in R&D expenses was primarily due to 21.9 million in lower expenses related to the acquisition and installation of manufacturing equipment for INO 4800 during 2021 that were non-recurring in 2022, and 7 million in lower engineering services and equipment related to our Selecta 3P device. These decreases were partially offset by an increase in drug manufacturing related to our COVID-19 variant studies and our DARPA COVID-19 Demad grant and lower contra revenue and development expenses recorded from our grant agreements, among other variants. G&A expenses were 48.5 million for the three months ended June 30th, 2022, versus 12.7 million for the same period in 2021.

The decrease in R&D expenses was primarily due to $21.9 million in lower expenses related to the acquisition and installation of manufacturing equipment for INO 4800 during 2021 that were non-reoccurring in 2022 and $7 million in lower engineering services and expense equipment related to our Selecta 3P device.

These decreases were partially offset by an increase in drug manufacturing related to our COVID-19 variant studies.

and our DARPA COVID-19 DMAD grant and lower contra revenue and development expenses recorded from our grant agreements among other variances.

Peter D. Kies: The increase in GNA expenses was primarily related to a $26 million increase in legal expenses, which includes a $14 million non-cash expense related to the anticipated issuance of our common stock as part of the proposed settlement of our previously disclosed security class action litigation and other related litigation costs, as well as a $6.9 million one-time severance expense related to the separation of our former chief executive officer during the quarter. To put in perspective, the proposed settlement in content, we anticipate paying 30 million in cash and issuing 14 million of common stock to settle all outstanding claims.

G&A expenses were $48.5 million for the three months ended June 30, 2022, versus $12.7 million for the same period in 2021.

The increase in G&A expenses was primarily related to a $26 million increase in legal expenses.

which includes a 14 million non-cash expense related to anticipated issuance of our common stock as part of the proposed settlement of our previously disclosed security class action litigation.

and other related litigation costs, as well as a $6.9 million one-time severance expense related to the separation of our formal chief executive officer in the corridor.

To put in perspective,

In the proposed settlement in content, we anticipate paying $30 million in cash and issuing $14 million of common stock to settle all outstanding claims.

Peter D. Kies: With the cash payment committed by the insurance carrier, While this settlement of the class action lawsuit remains subject to final agreement between the parties, as well as court approval, Accounting treatment of lost contingencies requires the accrual of the expense when it is probable and reasonably estimated. The company has recorded what represents our best estimate regarding the outcome of the class action lawsuit and proposed settlement. The proposed settlement is without any admission, concession, or finding of any fault, liability, or wrongdoing by the company or any defendant.

with the cash payment committed by our insurance carriers.

While this settlement of the class action lawsuit remains subject to final agreement between the parties as well as court approval,

Accounting treatment of lost contingencies requires the accrual

of the expense when it is probable and reasonably estimated.

The company has recorded what represents our best estimate.

regarding the outcome of the Class X and lawsuit.

and proposed settlement.

The proposed settlement is without any admission, concession, or finding of any fault, liability, or wrongdoing by the company or any defendant.

Peter D. Kies: Looking forward, our projections for the cash runway into the third quarter of 2024 include a cash pern estimate of approximately 73 million for the quarter, third quarter of 2022. Our expected cash burn will decrease incrementally from there into the third quarter of 2024. As a reminder, you can find the financials and the full financials in our press release and the full financials in our 10Q, filed with the SEC.

Looking forward, our projections for the cash runway into the third quarter of 2024 includes a cash burn estimate of approximately 73 million for the quarter.

Third quarter in 2022.

Our expected cash burn will decrease incrementally from there into the third quarter of 2024.

As a reminder, you can find the financials and the full financials in our press release and full financials in our 10Q filed with the SEC.

Jacqueline E. Shea: Now, with that, I'll turn it back to Jackie. Thank you, Peter. This past quarter, we have laid the foundations for a leaner, nimbler organization, with a sharpened focus on advancing our key programs towards commercialization. The decisions we have made and will continue to make reflect our commitment to realizing the potential of our DNA medicine platform to enable us to contribute to improving people's health globally. With that, let's now open the call for questions.

Now with that, I'll turn it back to Jackie.

Thank you, Peter.

This past quarter we have laid the foundations for a leaner nimbler organization with a sharpened focus on advancing our key programs towards commercialization.

The decisions we have made and will continue to make reflect our commitment to realizing the potential of our DNA medicines platform to enable us to contribute to improving people's health globally.

Jacqueline E. Shea: Operator. We will now begin the question and answer session. To ask a question, you may press star and then one on your telephone. If you are using a speakerphone, please pick up your handset before. To withdraw your question, please press Star. The first question comes from Jeff Meacham with Bank of America.

With that, let's now open the call for questions. Operator?

Thank you.

We will now begin the question and answer session.

To ask a question, you may press star then one on your telephone keypad.

If you are using a speakerphone, please pick up your handset before pressing the keys.

To withdraw your question, please press star then 1.

Your first question comes from Jeff Meacham with Bank of America. Please go ahead.

Operator: Please go ahead. Hi, this is Alex Hammond, Don on behalf of Jeff Meacham. Thank you for taking my question. Can you talk about how your COVID strategy has evolved following the push for AmherCon specific boosters? And what are your expectations for INO 40-100 commercial opportunities? Thank you so much.

Hi, this is Alex Hammond on for Jeff Meacham. Thank you for taking my question. Can you talk about how your COVID strategy has evolved following the push for OmerCon specific boosters? And what are your expectations for I&O 4,000 commercial opportunity? Thank you so much.

Jacqueline E. Shea: Thank you for the question. I'll start off and talk about the general strategy, and then I'll hand over to Dave for further specifics. So with regard to the change to Omicron vaccines that are being undertaken by some of the other companies, we continue to monitor all of these market factors, but we also need to keep in mind the increasing new evidence that heterologous boosts appear to have advanced years over homologous boosts in delivering broader protection against both current and newly developing strains of SARS-CoV-2.

Thank you for the question. So I'll start off and talk about the general strategy and then I'll hand over to Dave for further specifics.

So with regards to the change to Omicron vaccines that is being undertaken by some of the other companies, we continue to monitor all of these market factors, but we also need to keep in mind the increasing new evidence that heterologous boosters appear to have advantages over homologous boosts, and delivering broader protection against both current and newly developing strains of SARS-CoV-2. Our vaccine, INO 4800.

Jacqueline E. Shea: Our vaccine, I know 4,800, based on our vaccine, our DNA medicine technology has potentially several advantages that we feel could still allow it to play an important role in protecting health. Dave, would you like to add any other comments? Thanks, Jackie. I think the only thing I would add is to expand on what you said and mention the properties that we think are important that make this vaccine an excellent candidate to be a boost. These include its ability to elicit cellular responses against multiple variants of concern, which may be involved not only in protecting against severe disease and death but may also be critical for durability of protection. We lack an anti-vector response, and the tolerability for readministration and the safety profile that we've observed to date are all features that I think are important.

based on our DNA medicine's technology has potentially several advantageous characteristics that we feel could still allow it to play an important role in protecting health.

Dave, would you like to add any other comments?

Thanks, Jackie. I think the only thing I would add is to expand on what you said and mention the properties that we think are important that make this vaccine an excellent candidate to be a booster. These include its ability to elicit cellular responses against multiple variants of concern, which may be involved not only in protecting against severe disease and death, but may also be critical for durability of protection.

We lack an anti-vector response and the tolerability for re-administration and the safety profile that we've observed to date are all features that I think are important.

Thank you, Dave.

Dave: Thank you, Dave. Your next question comes from Gregory Renza with our, Please go ahead. Hi, good morning.

Thank you. Your next question comes from Gregory Renzar with RBC. Please go ahead.

Operator: Good afternoon, Jackie and team. Thanks for the update. Thanks for taking my question. Maybe I'm just starting with more of a high-level question. You've been on board for a few months now and in the CEO's seat for that time. I'm just curious, what are you learning?

Hey, good afternoon, Jackie and team. Thanks for the update and thanks for taking my questions. Maybe Jackie, just starting with more of a high level question, you've been on board for a few months now and the CEO for that time. I'm just curious, what are you learning? What are some of the surprises and maybe challenges that you're seeing? Maybe just weave in if you don't mind.

Jacqueline E. Shea: What are some of the surprises and maybe challenges that you're seeing? And maybe just weave in, if you don't mind, just how you expect, tend to employ the concept of setting expectations for disclosures, data, program progress, something that we're all monitoring as we should. And then last question that I'll just sneak in and then hop back into the queue. With respect to 3107 and the update coming, how important is RRP and, you know, 30107 to bear out the thesis with the pipeline? Thank you so much.

Just how you expect or tend to employ the concept of setting expectations for disclosures, data, program progress, something that we're all monitoring as we should. And then last question, and I'll just sneak in and then hop back into the queue. With respect to 3107 and the update coming, how important is RRP and N03107?

to bear out the thesis with the pipeline. Thank you so much.

Jacqueline E. Shea: Thank you, Greg. I think I'll start with the last part of your question, which is around the importance of RRP and 3107, and, you know, that really plays into our strategy generally. We're very focused on advancing those product candidates that are the closest to market. So those are our COVID vaccine candidates, I know, 4,800, and also our HPB-related product candidates, of which I know 31-190. Number 7 is, you just mentioned, and it's very important.

Okay, thank you, Greg. I think I'll start actually with the last part of your question, which is around the importance of RRP and 3107. And there it really plays into our strategy generally. We're very focused in advancing those product candidates that are closest to market. So those are our COVID vaccine candidates, I know 4800, and also our HPV related product candidates of which I know 3107.

Jacqueline E. Shea: So at OBO, you know, I would say over the past couple of months, really what we've been trying to do is realign our resources to really focus those resources on driving those product candidates forward, as we believe those candidates have the most potential for reaching the market in the near term. And I would say our strategy hasn't changed.

And I would say our strategy hasn't changed. We continue to be focused on driving those HPV-related candidates forward. We continue to be focused on the COVID vaccine cancers. I mean, obviously we're paying attention to the market environment and what's going on with COVID. We continue to pay attention as to how that may impact our development strategies. But we remain very optimistic that.

Jacqueline E. Shea: We continue to be focused on driving those HPB-related candidates forward. We continue to be focused on COVID vaccine cancer. I mean, obviously, we're paying attention to the market environment and what's going on with COVID. We continue to pay attention to how that may impact our development strategies.

Operator: But we remain very optimistic that 40, 400, can make a real contribution to the heterologous boost environment and that there continues to be a need for new, safe, and effective vaccines, particularly in the heterologous boost. Thanks, Jackie; I appreciate the caller. Once again, if you wish to ask a question, please, Your next question comes from Roger Song with Jeffries. Please go ahead. Great, thanks for taking the time to answer the question. A couple of honors

I know 4800 can make a real contribution to the heterologous boost environment and that there continues to be a need for new, safe and effective vaccines, particularly in the heterologous boost space.

Thanks, Jackie. I appreciate the call.

Thank you. Once again if you wish to ask a question please press star 1.

Your next question comes from Roger Song with Jefferies.

The next question comes from Roger Song with Jeffries. Please go ahead.

Great, thanks for taking the question. A couple found us, so for the 3100 kind of understanding you are waiting for the reveal to data to decide the next step but can you just comment what kind of data you are looking for in order for you to move forward into the pivotal focusing on the biomarker enhanced patient population.

Operator: So for the 3100 kind of understanding, you are waiting for the reveal two data to decide the next step, but can you just comment on what kind of data you're looking for in order for you to move forward into the pivotal focus on the biomarker enhanced patient population?